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Transcorneal Electrical Stimulation Therapy for Retinal Disease

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ClinicalTrials.gov Identifier: NCT00804102
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : May 4, 2012
Sponsor:
Information provided by (Responsible Party):
Okuvision GmbH

Study Description
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Brief Summary:
Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced secretion of neurotrophic substances and direct stimulation of neurons.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Macula Off Primary Open Angle Glaucoma Hereditary Macular Degeneration Treated Retina Detachment Retinal Artery Occlusion Retinal Vein Occlusion Non-Arthritic-Anterior-Ischemic Optic-Neuropathy Hereditary Autosomal Dominant Optic Atrophy Dry Age Related Macular Degeneration Ischemic Macula Edema Device: Transcorneal Electrical Stimulation Device: DTL-electrode attached without energy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transcorneal Electrical Stimulation Therapy for Retinal Disease - A Randomized, Single-blind Pilot Study
Study Start Date : January 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Retinitis pigmentosa Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Macula off
condition after treatment of retinal detachment
 Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Primary open angle Glaucoma Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Hereditary Macular Degeneration Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Treated Retina detachment Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Retinal Artery Occlusion Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Retinal Vein Occlusion Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Hereditary autosomal dominant Optic atrophy Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: dry Age-related Macular Degeneration Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Active Comparator: Ischemic Macula edema Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.
Sham Comparator: Non-stimulated Device: DTL-electrode attached without energy
DTL-electrode attached to patient eye receives no energy from neurostimulator. Treatment times remain the same as used for each treatment arm.


Outcome Measures
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Primary Outcome Measures :
  1. enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes [ Time Frame: 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary autosomal dominant Optic atrophy, dry Age-related Macular Degeneration, Ischemic Macula edema

Exclusion Criteria:

  • Severe other disease such as non-proliferative diabetic retinopathy, exudative Age-related Macular Degeneration
  • Age above 99 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804102


Sponsors and Collaborators
Okuvision GmbH
Investigators
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Principal Investigator: Florian Gekeler, MD, Prof University-Eye-Hospital, Centre for Ophthalmology, D-72076 Tübingen, Germany
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Okuvision GmbH
ClinicalTrials.gov Identifier: NCT00804102    
Other Study ID Numbers: EST-2008
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012
Keywords provided by Okuvision GmbH:
Retinitis pigmentosa
Macula off
Primary open angle Glaucoma
Hereditary Macular Degeneration
Treated Retina detachment
Retinal Artery Occlusion
 Retinal Vein Occlusion,
Non-Arthritic-Anterior-Ischemic Optic-Neuropathy
Hereditary autosomal dominant Optic atrophy
dry Age-related Macular Degeneration
Ischemic Macula edema
Additional relevant MeSH terms:
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Optic Nerve Diseases
Optic Neuropathy, Ischemic
Optic Atrophy
Optic Atrophy, Autosomal Dominant
Glaucoma
Macular Degeneration
Glaucoma, Open-Angle
Retinitis
Retinal Vein Occlusion
Retinitis Pigmentosa
Retinal Diseases
Retinal Artery Occlusion
Retinal Detachment
Ischemia
Atrophy
 Pathologic Processes
Ocular Hypertension
Eye Diseases
Retinal Degeneration
Pathological Conditions, Anatomical
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn
Arterial Occlusive Diseases
Cranial Nerve Diseases